What is a CDMO and Why Do Pharma Companies Need One?

Posted by Abhishek Kumar on May 1st, 2023

Pharmaceutical companies are facing mounting pressure to complete drug development projects within tight timelines, given the increasing demand for new drugs. However, this process is intricate and necessitates access to specialized facilities, which can impose significant financial burdens on these companies. To alleviate this challenge, pharmaceutical companies frequently collaborate with contract development and manufacturing organizations (CDMOs).

In this article, we are going to discuss CDMOs in brief and also see why such companies are so important for pharmaceutical companies.

What is a CDMO?

A CDMO, or contract development and manufacturing organization, is responsible for managing the outsourced manufacturing of drug substances. It also oversees the developmental work that precedes manufacturing, which encompasses development, production, and analysis. CDMOs provide a range of services to pharmaceutical companies, such as formulation, blending, coating, converting, packaging, serialization, and shipping.

Difference Between a CMO and CDMO?

Pharmaceutical companies contract CMOs, or contract manufacturing organizations, to manufacture drug substances. This can include the production of solutions, emulsions, nano-suspensions, liquid-filled capsules, aseptic filling, terminal sterilization, pre-filled syringes, and vials, as well as tablets and capsules.

Many pharmaceutical companies opt to outsource drug manufacturing due to the high costs associated with purchasing specialized equipment for the mass production of certain chemicals. Outsourcing is often more cost-effective than investing in such equipment, especially if a product fails in clinical research and subsequent development and production are canceled.

CDMOs, or contract development and manufacturing organizations, take on not only the outsourced manufacturing of drug substances but also all of the innovation and development work that precedes manufacturing. This includes development, production, and analysis, allowing pharmaceutical companies to forgo building and staffing dedicated innovation and manufacturing facilities.

CDMOs typically offer a range of services, including formulation, analytical services, blending, coating, converting, packaging, serialization, and shipment. They can start with a concept or a ready-to-go formula, offering pre-formulation and formulation development services, as well as clinical trials and commercial production.

Why do Pharma Companies need a CDMO?

There are multiple reasons why pharmaceutical companies prefer to partner with a CDMO. Some of these reasons are as follows:

1. Helps in reducing the costs of infrastructure

A CDMO has access to equipment and facilities. This assists pharmaceutical businesses in reducing or eliminating the requirement for extra production and manufacturing space. It also helps to reduce the expenses associated with the procurement of specialist equipment.

2. Helps in meeting drug production deadlines & increased demands

Drug development and production can be a complex and time-consuming process. With the right CDMO that comes with specialized equipment and facilities, drug development deadlines can be easily met by pharmaceutical corporations. In fact, pharmaceutical companies can also shift production volume, add drug variations, and get additional facility space to meet the increased demands. 

3. Helps in accessing additional expertise

Another reason why pharmaceutical companies require a CDMO is that they can have access to some additional expertise. As a result, they can tap into researchers with specialized skills that can help them in their upcoming drug development projects. 

Things to Consider While Partnering with a CDMO

Now that we know what a CDMO is and why pharmaceutical companies require them, let’s now see what you need to consider while choosing a partnership. The important things to consider while choosing a CDMO partnership are as follows:

1. The right expertise and experience.
2. Specialized facilities and equipment.
3. Experienced team.
4. The ability to help you to cut costs and allow you to deliver before deadlines.
5. Alignment with your company’s vision and goals to get the most fruitful results.

Thus, when choosing a CDMO for your drug development and manufacturing needs, it is important to consider their experience, expertise, and capabilities. Ensure that they have a regulatory compliance record and the necessary resources and infrastructure to meet your specific needs.

Additionally, it is important to look at their track record of successful projects and customer service experience to ensure that they have the right combination of resources, capabilities, and experience to meet your needs.

Finally, it is important to look at their pricing structure and terms to ensure that they are offering a competitive and fair price for the services they are providing. Read this blog to learn more about things to consider before partnering with the CDMO in detail.